A randomised clinical trial evaluating the benefits of doxorubicin chemoembolisation (CEM) versus systemic doxorubicin in patients with unresectable, advanced hepatocellular carcinoma (HCC)

Completed

Conditions: nresectable, advanced hepatocellular carcinoma
Cancer
Liver

Registration Number: ISRCTN78345798

Lead Sponsor: The University of Birmingham and University of Edinburgh (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 280

Inclusion Criteria

1. Histological or cytological diagnosis or The European Association for the Study of the Liver (EASL) criteria met for unresectable HCC
2. No prior systemic or regional chemotherapy
3. Aged greater than or equal to 18 years (or greater than or equal to 16 years in Scotland)
4. Laboratory parameters:
4.1. Haemoglobin (Hb) greater than or equal to 8.5 g/dl
4.2. Platelets greater than or equal to 100,000/mm^3
4.3. Absolute neutrophil count (ANC) greater than or equal to 1500/mm^3
4.4. International normalised ratio (INR) less than 1.5
4.5. Bilirubin less than or equal to 50 µm/L
4.6. Transaminases less than 2.5 x upper limit of normal (ULN)
4.7. Serum creatinine less than 2 x ULN
5. Eastern Coooperative Oncology Group (ECOG) performance status less than or equal to 2
6. Modified Pugh's Child B grade or better
7. Not of childbearing potential or using an approved method of contraception
8. Written informed consent

Exclusion Criteria

1. New York Heart Association (NYHA) Class III/IV cardiac disease
2. Left ventricular ejection fraction (LVEF) of less than 50% or acute anginal symptoms
3. Thrombosis of main portal vein
4. Main portal vein occlusion/involvement
5. Patients whom in the opinion of the investigator have 'clinically significant ascites'
6. History of second malignancy within 5 years prior to trial entry, excepting cervical carcinoma-in-situ or non-melanotic skin cancer
7. Previous chemotherapy, radiotherapy, biological or hormone therapy given for hepatocellular carcinoma
8. Any ablative therapy for hepatocellular carcinoma within the last 6 weeks. Radiological evidence of progression is required if assessing a previously ablated site as the only site of disease.
9. Use of other investigational agent during the study or within 4 weeks of planned study entry
10. Major surgery within 7 days or laparoscopy within 3 days of trial entry
11. A serious co-existing medical condition including a potential serious infection or significant peripheral vascular disease
12. Psychological, familial, sociological or geographical factors considered likely to prevent compliance with the protocol
13. Presence of extrahepatic tumour of any kind